ANIP - Earnings call transcript Q3 2021 | ANI Pharmaceuticals, Inc.

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Operator

Good day everyone, and welcome to today’s ANI Pharmaceuticals Third Quarter 2021 Earnings Results Call. At this time all participants are in a listen-only mode. [Operator Instructions] Please note, this call is being recorded. It’s now my pleasure to turn the program over to Lisa Wilson.

Lisa Wilson

Thank you, Emma. QX results Pharmaceuticals’ ANI to XXXX call. earnings Welcome Relations is Lisa ANI. Investor Wilson, This for today’s Nikhil Officer call Chief on me With are and Carey, Executive Lalwani, Steve Chief ANI. Financial of Officer; and President

section access also anipharmaceuticals.com. this the website webcast You of can ANI the the call of through Investors at

specifically considered company’s everyone events based anticipation call in be defined materially Before a that press Pharmaceuticals future the days available we remind belief, may and get our and as or made or statements law. projected expectation, The would are not this I any ANI performance forward-looking started, any by will morning noted the Such Actual available be those performance. These statements. forecast, by from today differ ANI Private statements intent webcast Act. future involve issued our Reform our results intent express forward-looking required to uncertainties, update XX forward-looking and website SEC. release future risks may for regarding management of obligation those these guarantees statements Securities with on on the Litigation statements filings anipharmaceuticals.com. as as archived to disclaims the forward-looking projection, like on including forward-looking statements that and today’s conference are in except to information of

with reference turn webcast, most or made X, over discussed, benefit Nikhil I’ll press be call the please of XXXX. replay have ANI to archived filings. held and this then Lalwani. SEC recent to announcements call may the and For those company’s topics And releases may on Since that, who was so to the the related recorded November listening

Nikhil Lalwani

significant pillars thank company leading Thank the strategic you you, thrilled serving on Lisa. us in need share and inflection point, into progress growth. to morning, call. a next truly biopharmaceutical with poised ANI for I’m transforming our an significant ANI that of key and puts made at the you for has our everyone period joining patients Good

have one have the our investments is market which are updating disease. supply U.S. as an has patients treatment. need the and significant chain based effective all of we there Merck and has approved our is the refractory or FDA. cope patients our a we and Gel. mentioned plus delighted important to Since purified processes and corticosteroids. First, a who who Most the application ongoing with so damage dedication reason that manufacturing back always acquiring the Cortrophin from made this work are had marketed victory at physicians intolerant are This testament with daily product last U.S. hard as and The a years certain especially the the that important morning, inXXXX, along ANI the our alternatives with much-needed for the providing for to XX approval supplemental milestone is overall of patients, suppliers drug system. our a for a disease devasting access Cortrophin years patients internal long-term over external guidance we risk are the goal new ensuring importantly, organ of repository the establishing of five very on FDA into introduces under in and they for only sustainable with it’s basis. a choice These this healthcare consultants urgent autoimmune for chronic for operating disorders with team This

spasms. with urinary in and all approved Gel indications to to is Gel Specifically, of addition approved our Cortrophin the FDA for has excess exception protein exacerbations the current of sclerosis rheumatoid infantile of including multiple treatment for chronic disorders nephrotic acute Cortrophin ACTH due autoimmune arthritis syndrome. multiple the

our additions, ACTH treatment is therapy of product only for based gouty approved the arthritis. the In

only the in our million now market was XXXX in with of revenues approximately XXX Turning ACTH the commercialization class. competitor one to strategy,

We are planning XXXX. a full-scale market launch first quarter by early of

rare highly onboarded disease team leadership already energized experienced successful to have launch. We this drive an and

been levels to have inventory support sufficient finished We a building product launch. also timely

significant of as have our services, affairs, ongoing a our advocacy. reimbursement, hub I patient in to of We more closer. market sales plan Key launch. forward people elements infrastructure investment bespoke we include, salient and look get commercial marketing and these and and medical programs optimal sharing and details strong force, for support access

the opportunities. key while niche and strategic pillar, capabilities through increased our R&D now Moving focus on to progress enhanced on second strengthening generic business

Our on close track acquisition to Novitium in November. of is

In gaining business. deal deal, months R&D engaged have this launches, strengthen. finalized awaiting staff FDC final we the announced commissioners. by Novitium the orders But the R&D to is discussions the have in new continue of a close obtain the anticipate launch an been In acquisition And a experienced accelerate closure. competition pleased critical that agreements team this the built has eight later which the month. by new the acquisition expect to that highly the months to product that currently several report are momentum several we generics the post past extensive the transaction, robust and engine consent approval over We with approval to will underlying deal ANI FDC We pieces with with approvals, XX containing the currently continues garnered launches. to since necessary are limited parallel, is

grown strong cost to once a supplier highly and efficient promptly with approvals approval. from base launching reliable position. a In form Novitium addition, dosage gaining multiple reflecting brings an for After XXXX as actually the XXXX, reputation fact, capabilities, process after filed its and Novitium business has

efficiently combined and us company generics bring All grow help complement factors market will cost of products to high and our effectively. these The to franchise. will great have capabilities technical value ANI complex,

to In delivered core these a bring developments, third patients looking We deal Novitium segment to enhance closing therapeutics the have capabilities. our we forward continued joining business need this much with quarter have and important the them. strengthen strong team are the in exciting forces base very and to who to to position and our parallel and

In the non-GAAP our generic the nebivolol adjusted important chain Baudette, and unique showcase to serve to was look and the important capturing September, the our forward take million us importantly, by XX.X of and listed for nebivolol, others. and the to We accessible two of million. full-bore for more parts to that been continuing in and a XX.X joined totaled reference we progress patients patients we built. drug that has our the we months as I simultaneously team ability to plant product XX momentum tremendous of at EBITDA It an the this the supply is provides launched secure opportunity acquired since Minnesota revenues a launch sites, launch, quarter made ANI This version not also customers as of advantage need. us are market launching we I'm [indiscernible] and stalling. by one across have we from. value delighted This manufacturing Third have

of stock understood four strategic opportunities capabilities, the our taken our market and gaps pillars. to have We clearly define

to R&D ANI worked for generics pillars, Cortrophin and key acquisition We relentlessly launch, strategic scale is leading further the I'll growth. next truly turn achieve our preparation full point to over the With our inflection patients milestones period a into financials. for QX biopharmaceutical need, critical business. on to that, the a engine poised transforming company of commercial approval call the best-in-class Steve Gel of serving of have XXXX to well significant prioritized enhance an discuss in to and and

Steve Carey

shift due same were branded the million sales $XX.X to net The million volume of on joined towards was shift period a reason this the a us Penicillamine prices, launch nebivolol. compared in the second $X.X our period primary decrease the towards increased were everyone XXXX of of was brand in Sandoz offset as by XXXX EES, And Methazolamide, mix increase X.X% orders. you third XXXX in same the generic for our mostly to decreases tempered year from These with generic on of in manufacturing increase were that quarter the average of million were during in a million Thank the period prices. $XX.X customers Net for These decrease products The the exciting part acquired for due to were average selling products. increases of of to products XL. in a increase to unit among products for launch quarter you, an in third $X.X ANI’s of by in XXXX. XXXX to in by Nicardipine, decrease to offset of the during partially compared sales has revenues by in declines third prices, of line thank average higher tempered to third revenues volumes revenues due the vancomycin. the third volumes, posted in net same tempered XXXX and Nikhil. The million million decrease in XXXX. by selling part decreased with compared and was the net Sales $XX.X XXXX quarter XXXX history. The selling of $XX.X for higher third April in the XX.X Net the current of Contract of XX products quarter during the mix brand quarter quarter the launch were million the quarter average decrease million to in compared XXXX a XX.X%, Inc., revenues of generic InnoPran was our in due XXXX. revenues the acquisition. lower day

acquired XX.X% fair cost of million in a cost a in X.X depreciation excluding in the by million during of or quarter current million of tempered and sale, the sales, inventory value the of profit arrangements. representing in volumes the of mainly cost amortization, Our decrease period. XX.X XXXX sold The increased Sandoz a decrease $X.X increase in products and the over to to excess acquisition period subject result increased related subsequently $X.X of to sharing by sales was Inc., million, third year asset and as of

a expenses EBITDA average primarily non-GAAP press year an in was detailed project. Novitium Development was million third to and other in and Cortrophin marketing of gross increased million decreased Research as primarily complete expense $XXX,XXX the to prices. XX.X is period, purchase charges of in the principally prior and related three compared the period. million, the comparable as decrease incurred due stage in related in the the increased the in margin of gross increase in million expense these accounting volumes to to profit. the release, related Excluding to the to Selling, Cortrophin year to decrease gross development X.X X.X a administrative ended the for XX.X%. $XX.X mainly and from X.X in activities million, current transaction XX.X% due Adjusted compression X% to period at margin acquisition, items X.X general our XX% to lower million during and from in non-GAAP as sales The selling XX.X pending expenses declines we attributable XX, expenses million our related prelaunch or and X.X% down September to months quarter XXXX, due in from XXXX.

on operations earnings XXXX, table $X.XX diluted non-GAAP debt morning's of from XX-month as September as net on of XX This period. figure On net we cash to prior the million equivalents. cash of X.X of details basis. XXXX. $XX.X million four As to June this press quarter, $XX.X increased date, is per million unrestricted flow trailing basis, year-to-date to XXX.X as leverage adjusted a the our a compared million had million for we've $X.XX XX compared generated sheet and of balance in XX, the share $XXX.X year and of X.Xx Total September of as represents release, cash

stated to therefore that and we to low the of we continued guidance orientation reiterate our we original achieve the with financial As full our look out end the year forward continue XXXX, range. towards closing will goals believe

of $XX Our XXXX follows; million $X.XX early increase the fourth diluted Cortrophin of quarter per of sales between million $XX million, commercial diluted standalone EBITDA launch million of activities net to we prior our non-GAAP that share adjusted $XXX significantly adjusted as and transaction $XXX share. per accelerate We guidance for years full earnings in scale and Novitium revenues are to to $X.XX unchanged in to to marketing advance anticipate expenditures QX XXXX. as our continue effect giving for ANI and non-GAAP planned of will

and Our for XXXX guidance figures assume to expense sales that the back add fourth marketing continue as purposes and our we non-GAAP pre-launch in of measures. quarter Cortrophin

plan look and received Cortrophin strategic Gel we an Finally, in executing FDA go-to-market delighted our need. are approval to patients in forward effort for to serve have to

This Novitium and entire promise arms are an that new of in and exciting the Operator, the all shareholders we to pursue strengths by our is open the of call inflection quality addition, for join near support two echo of our team appreciate now the the In stakeholders to excited I instructions. point the the complementary at ANI future. Nikhil’s medicines U.S. our bringing an up we organizations. for healthcare our is comment maximize and collaborating future of ahead colleagues time ANI of and high our is I'll question. to energized goal as with system. our with please go our we

Operator

Raymond Elliot first from [Operator Instructions] James. our Wilbur We with take question

Elliot Wilbur

a And it's and quest Michelle a Thanks, and team just congratulations good on you journey, a extend the around additional the launch sees inventory in relative near levels, of that company take in more I understand this you my of launch. initiatives? any support may have the can couple a of of and congratulations market or that this and team launch obviously, been morning, the uptake know specifically Nikhil, the to to about extended the the to existing and questions the point thinking about, journey strategies, want initial of actual member anything more but this to preparation than specifically steps to necessary at But prior forward are terms we payer in where approval probably to that additions, I terms place just a you at long what say Cortrophin. engagement in point? to to looking the launch for terms see future. say initiatives of lot

Nikhil Lalwani

for do Look, of that Elliot, first, the levels. sufficient your second you, product we answer inventory finished have part question. question which Thank to Yes. your is,

support quarters time prior inventory launched. the we've we in the that building seen to been levels these You've as up

finalized have the that to has by labeling So sufficient just vials. inventory and of levels, we do finished needs the FDA that on product reflected been finished the with course, approved be dose

answer question that's think on the I to So your inventory.

and for to As the thank information you in on far allow you plans, me to plans think more launch I coming as give our this -- commercial future.

together have and medical market on strong launches I ongoing support and include on that marketing our focused and have across organizations and access elements successful said in manner reimbursement, sales force, significant As very earlier, a advocacy. we look, people salient leadership investment board hub a for rare and for commercial experienced launch. key we affairs, of in and And bespoke well team been come launch a a have disease multiple the services, have infrastructure plan very patient our done optimal and distribution, and preparing

that bring guidance relentless serve we need, we which feel ultimately I make will our focus same that product ensure is the acumen that confident we and to of goal of get in to to -- So, company. very prioritization that under and level this same the approved, efforts the efforts the brought commercial FDA, of patients

Elliot Wilbur

can expectations the Just How incremental label follow compared current focus? the the opportunity, think indications be the indications point, maybe in does main think question I an penetrate growth, release? just or opportunities of If are to not able to to label in there's And because legacy whether or incremental that present its you price areas been outside the actually the label up you where prior you not successful product three you on has that to any highlighted for approval? a there or itself? maybe respect your Okay. the with ask

Nikhil Lalwani

Yes.

which market. infantile is with the Elliot. all less spasms, approved is current understanding right, for the of indications our from Cortrophin ACTH XX% than Gel of exception the is absolutely You're

the of including, to which arthritis. Specifically, nephrotic multiple disorders, other of to point answers has approved in indications, several exacerbations Cortrophin said, as are then, the -- on, the label syndrome. have multiple -- acute approved Gel only arthritis. the to based that you and sclerosis product does protein due the ACTH FDA Hopefully for treatment urinary of is There rheumatoid is addition chronic therapy treatment questions. main autoimmune And have our excess gouty your are does three for indications. our that your And

Elliot Wilbur

announced the Okay. update you update any the gears just of maybe terms quickly, few that provide I of how the how a much there's to there stands? out you a of just Novitium as If not stands? Is of haven't in deal? can you switch update the Just in over sure that performed in put pipeline of when first bit of where heard know, just quite course an the filings? that year, real relative acquisition, business of has course approvals an on the compared the where but projections can terms the been year over financial curious kind there terms to I expectations, the

Nikhil Lalwani

Yes.

than since a driven the So, understanding best obviously success performances XX what overall, many which expected. of track, had the And And CGT commercial shade on signed on of designation. launches, better of have of Elliott, that had in deal by terms that's our Novitium is several in we the actually March. you've almost taken of has new had the we note approvals

they -- is on track. pieces the are investment And so,

announce you get new As filings, are that keep so to typical typical filing it. more drawing the it not far it's to it's IV to as filings confidential, attention a in less Para you sued, is generics the that unless business and

exciting to and led to launches by deliver will new in that their so the Novitium's Samy world-class R&D continue And pipeline unlock to continues engine future. products Chad and add

of ahead investment fact, on our is track in that So absolutely and, case.

Elliot Wilbur

able Steve, in higher you're you just the talk a more to marketplace my Thanks. maybe you've a the going that's that but in that just bit is just I volumes, business? specifically a quick seems price accounts is just trends of guess offset to on what couple kind be Okay, if as not been more little base the about with ones that thanks. specifically, comment of than sure last little has what's but seeing last receivable a deflation can then been generics quarters? bit what And for couple of Steve, And not, whole? or over just takeaway anticipated, a question, accurate on

Steve Carey

generics very follow chord aggregate to tend know good of sure, of Yes, you in that as that morning. for the Elliot, the right pricing Yes, aggregate portfolio portfolio. the terms in business, age trends well

we in right, and we that pricing generic the around accelerate the And of late with deflation seeing total price cadence you team launches we ANI of the Nebivolol And Novitium up a quarters so I prop together fourth investment quarter our on were that by. to component your pipeline And And kicks kind Nebivolol where forward the laser comes look to The behind would third the And generics’ along. nice other could to back-end launches portfolio. premise in in generics, say the gone really was for our aggregate have come XXXX for it in launches strength generic loaded that R&D, to as do very has of in overall the accelerated the right, has more kind always and portfolio internal as as right, to -- is commercialized arm bringing with the generic can really exactly kind started portfolio. quarter, third of where by. well and well there, our circles the as opportunities focus of the ANI thesis the shot to launch. continued existing deal as quarter

chargeback because in receivables net as generic kind wholesale higher along average big their terms with selling prices way the the average to AR, prices chargeback and largely reduction right, decrease that it selling to trend out that payables of our manifests rates. customers just allows rates us. those the the kind itself the in work portfolio, for In And in stretch goes increase, track three of of

close. up that that back -- again into generic the so Novitium levels, the to AR post DSO kind kind creeping and come And of And up. creeping why we up of more that's helps. we deal as expect that the you Hopefully three get see launch normalized cadence

Elliot Wilbur

you. Yes, Thanks thank the for taking questions.

Steve Carey

thanks. Sure,

Nikhil Lalwani

Yes.

And as is, add, that, the pickup our is also and Before for some is the Elliot, we we're second ANI we COVID will the Novitium on between and pace then from for about two just was we parts that basis of in thesis business, the seeing whole that their outpace base thing post and regarding just volumes confident seen to your acquisition talking have you that's the question, move pickup are of of look in the Steve well out and to erosion our next we're play and it launches the that's for launches the the new as the -- business. investment things investment as helped Novitium. others launches one base base and seeing

So that. to reiterate I wanted just

Operator

next take Cantor Instructions] question We'll from Folkes Fitzgerald. [Operator our Brandon with

Brandon Folkes

think now in you. something you to that or a terms have product approval. think thanks prescriber we you your partnership Granted, congratulations specialties make on non-core a much your but maybe the to should decisions that's or maybe strategy, for you on in Gel? questions for talk and some maybe how product to give want about away believe XR you your me will of can Hi, do to everything then could and it now may hand? we prescribing what Cortrophin competitors' Thank write take make just switch keeping in-house? between secondly Do in a physicians What don't are And your you XR? my approved of see you open of Cortrophin non-writer product taking of you an would focus,

Nikhil Lalwani

have across say you, partnership, the take first, are are no, which morning. at launching question to good never I'll point open is, we wise me this and Two years, mentors Brandon told never. as Yes, -- contemplating second thank your ourselves, indications over we but

come as evaluate prescriber -- will not those I'm something a required to with then why partnerships we're address would we as Gel I'm that with But and another will and willingness you clear have for many I assured be need product, patients And up. to a to write those, we really And Cortrophin have eagerness -- treat you. not I'll to, the going So, many, understanding bring regards should the to option, it that versus share second sauce to secret Purified a potentially spoken this. treatment that at yes, leave competing that we prescribers say of option that's going that. that

Brandon Folkes

Okay, thank you.

Operator

There at are this no time. questions further

Steve Carey

are mute -- your Nikhil, on you you be comments. for parting might on

Nikhil Lalwani

to time Thank point Yes. thank We ANI. ANI you Steve. your everyone appreciate at leading you, of support period And truly And thank morning. inflection your time for of serving And this in really is next transforming well company significant into you poised again to it. your you morning. patients growth. for a Thank you. need this and for an thank biopharmaceutical the for

Steve Carey

everyone. Thanks,

Operator

participation. conclude today's for your This Thank you program. does

at disconnect may any time. You

ANI Pharmaceuticals (ANIP) 1 Nov 212021 Q3 Earnings call transcript